Systems and methods for removing ingested material from a stomach

ABSTRACT

When a patient is fitted with an external gastrostomy connection to the stomach, ingested food can be removed through the gastrostomy connection using a pump-based or siphon-based system to achieve weight loss. The process of removing ingested food can be improved by alternating the infusion of liquid into the stomach with the removal of material from the stomach. Optionally, stomach acid may be captured and returned to the stomach. Optionally, nutritional supplements or medicines may be added to the infused liquid. Optionally, a flush mount connectorized system with a built in valve may be used to simplify the interface with the gastrostomy hardware that remains installed in the patient. Optionally, the system may be configured to disable itself from further use after a triggering event (e.g., the passage of time or a predetermined number of uses) has occurred.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. provisional application No.60/821,333, filed Aug. 3, 2006.

BACKGROUND OF THE INVENTION

The invention generally relates to removing ingested material from astomach of a patient, and the primary intended fields of the inventionare facilitating weight loss and preventing weight gain.

BRIEF SUMMARY OF THE INVENTION

In one aspect of the invention, food that has been ingested is removedfrom the patient's stomach via a gastrostomy tube using a siphon action.In another aspect of the invention, food that has been ingested isremoved from the patient's stomach via a gastrostomy tube, and theremoval of food is facilitated by infusing fluid into the patient'sstomach via the gastrostomy tube. In another aspect of the invention,matter that has been ingested is removed from the patient's stomach viaa gastrostomy tube, and stomach acid is separated from the removedmatter and returned to the patient's stomach. In another aspect of theinvention, matter that has been ingested is removed from the patient'sstomach via a gastrostomy tube, and the system is configured to disableitself from further use after the occurrence of a triggering event(e.g., the passage of time or a predetermined number of uses).

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of an embodiment of the inventionfor removing ingested material from a patient's stomach.

FIG. 2 is a schematic representation of a first embodiment forimplementing the system shown in FIG. 1.

FIG. 3 is a schematic representation of a second embodiment forimplementing the system shown in FIG. 1.

FIG. 4 shows a side view of a third embodiment for implementing thesystem depicted in FIG. 1.

FIG. 5A shows an isometric view of the FIG. 4 embodiment.

FIG. 5B shows a front view of internal components of the FIG. 4embodiment.

FIG. 5C shows a back view of internal components of the FIG. 4embodiment.

FIG. 6A shows an isometric view of another embodiment for implementingthe system depicted in FIG. 1.

FIG. 6B shows a front view of internal components of the FIG. 6Aembodiment.

FIG. 7A schematically shows an embodiment of a system for removingingested material from a stomach, filtering select gastric contents, andreturning filtered fluid to the stomach.

FIG. 7B schematically shows an embodiment of a system for removingingested material from a stomach, filtering select gastric contents, andreturning filtered fluid and water to the stomach.

FIG. 8A shows a patient with a skin connector coupled with a gastrostomytube that is inserted into the stomach.

FIG. 8B shows a view of the skin connector prior to mating with a tubeconnector.

FIG. 8C shows a view of the skin connector mated with a tube connector.

FIGS. 9A, 9B, and 9C show side, top, and isometric views of a skinconnector valve assembly for the embodiment shown in FIGS. 8A-8C.

FIGS. 10A, 10B, and 10C show side, top, and isometric views of anassembled flush skin connector for the embodiment shown in FIGS. 8A-8C.

FIGS. 11A, 11B, and 11C show side, top, and isometric views of a skinconnector flange assembly for the embodiment shown in FIGS. 8A-8C.

FIG. 12 is an exploded view of the rotational valve assembly for theembodiment shown in FIGS. 8A-8C.

FIG. 13A shows a bottom view of a tube connector assembly for theembodiment shown in FIGS. 8A-8C.

FIG. 13B shows a side view of a tube connector assembly for theembodiment shown in FIGS. 8A-8C.

FIGS. 14A and 14B show the tube connector connected to the skinconnector of the embodiment shown in FIGS. 8A-8C, in the closed andopened positions, respectively.

FIG. 15 shows the embodiment shown in FIGS. 8A-8C being used by apatient.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This application discloses methods and apparatuses for removing materialfrom a patient. In the exemplary embodiment disclosed herein, themethods and apparatuses are used for removing ingested material from apatient's stomach in patients that have been fitted with a gastrostomytube. Examples of suitable gastrostomy tubes are described in U.S.Patent Application Publication Nos. US 2004/0220516, US 2005/0277900 andUS 2005/0283130, each of which is incorporated herein by reference.Additional gastrostomy tubes are described in U.S. Provisional PatentApplication 60/806,556, which is also incorporated herein by reference.

The primary contemplated use for the methods and apparatuses describedherein is achieving weight loss in obese or overweight people. Althoughthe exemplary embodiments are described herein in the context ofremoving ingested material from a patient's stomach, the methods andapparatus can also be used for removal of a variety of fluids from apatient (with, when necessary, appropriate modifications that will beapparent to persons skilled in the relevant arts).

FIG. 1 shows a patient 10 that is fitted with a gastrostomy tube with asystem for removing ingested material from a stomach. An example of sucha gastrostomy tube 45 is shown in FIG. 8A. The gastrostomy tube 45interfaces with the outside world via connection 14, so the systemcommunicates with the gastrostomy tube 45 through that connection. Thesystem preferably includes an assembly 16 for infusing fluid into thestomach through the connection 14 in a manner permitting the fluid tomix with the ingested material or, for use in priming the system whendesired, and a drain line 18 for draining content of the stomachreceived from the connection 14.

The drain line 18 may be in communication with the assembly 16, asshown. In alternative embodiments (not shown), the drain line 18 may beimplemented independent of the assembly 16. For example, one line may beused to drain content of the stomach through the connection 14 andanother line may infuse the fluid into the stomach through theconnection. The system preferably includes a patient line 20 incommunication with the assembly 16 and the connection 14 to the patient10, and the patient line 20 preferably has a suitable connector at itsupper end that mates with the connection 14. In alternative embodiments(not shown), the assembly 16 may be coupled directly to the externalgastrostomy connection 14 without using an intermediate patient line.The assembly 16 may include a fluid source and may optionally include avalve arrangement and/or one or more pumps as described in more detailbelow.

In operation, the system is connected up to the connection 14 to removethe contents of the stomach via the connection. In some embodiments, theremoval may be accomplished by pumping the stomach contents out via theconnection 14. In alternative embodiments, this removal is accomplishedby setting up a siphon system so that the contents of the stomach can besiphoned out of the patient's stomach.

In siphon-based systems, the drain line 18 preferably has a length inexcess of 25 cm in order to create a pressure differential that issufficient to form an effective, efficient siphon that can gently andpassively drain content from the stomach. However, in alternativeembodiments, the drain line 18 can be of a length less than 25 cm. Notethat when the patient is standing, the overall siphon system is measuredfrom the lowest point in the tube or line that is inserted into thestomach to the end of the drain line 18. Optionally, the siphon systemmay be designed to be long enough to run from the stomach of a standingpatient to a position proximate to a floor-based disposal arrangement,such as a toilet or waste container. The drain line may include a siphontube made from flat, collapsible tubing or other flexible tubing.Silicon is a suitable material for the patient line 20 and the drainline 18. However, in alternative embodiments, the patient line 20 can bemade from any material known and used in the art of tubes or anymaterial that could be used to impart the necessary function of thepatient line 20.

In some situations (e.g., when the patient has drank a significantamount of liquids), an effective siphon effect can be achieved withoutinfusing any liquids into the patient's stomach. In other situations,however, it may be necessary to add additional fluid into the patient'sstomach to help start up the siphoning, so that the ingested materialcan be effectively removed from the patient's stomach. This may be doneby having the patient drink additional fluids or by infusing additionalfluid into the stomach through the connection 14.

In many cases, a single siphoning operation will be insufficient toremove the desired amount of ingested material from the patient'sstomach. In those cases, it is desirable to introduce additional liquidinto the stomach so that one or more additional siphoning operations canbe done. A preferred approach for introducing additional liquid into thestomach is by infusing the liquid into the stomach through theconnection 14. For example, after eating a meal and drinking liquids,the subject may attach the device to the connection 14, and siphon out alarge portion of the stomach contents (e.g., fluid with solidparticulate, pieces, and/or chunks of food). For a typical meal, thevolume of this initial siphoning operation may be on the order of 750cc, but that number will of course vary based on the volume andcharacteristics of the ingested meal. Once the siphon effect stops, thesubject infuses water back through the connection 14 into the stomachand then initiates another siphoning operation to remove the infusedwater, which will carry out additional solid food particles, piecesand/or chunks. The infusing and siphoning steps may then be repeateduntil the desired amount of ingested material is removed from thestomach. An example of a suitable volume for infusing into the stomachduring the infusing step is 180 cc, although any other volume may beused.

Note that the methods described herein are preferably used to remove asignificant portion of the food that the patient has ingested (e.g.,between 30 and 60%, and more preferably between 40 and 50%, of theingested food). Removing all the food that was ingested by the patientis not preferred and will usually be impractical. Examples of systemsthat implement both the removal of ingested material and the infusion offluids are described below.

FIG. 2 schematically shows a first embodiment of a system foralternately removing ingested material from a stomach and infusing fluidinto the stomach. The fluid may be any biocompatible fluid such as wateror saline, and may optionally include one or more nutrients and/ormedications. As shown, the assembly 16 includes a fluid source 22 and avalve arrangement 24 in communication with the fluid source 22, thedrain line 18, and the patient line 20. The valve arrangement 24 mayinclude one or more valves and any type of valve, such as, but notlimited to, check valves, blade occluder and diverter valves. Forexample, the valve arrangement 24 may be implemented using a single3-way valve with two operating positions—one position that opens a pathbetween the patient line 20 and the drain line 18, and another positionthat opens a path between the fluid source 22 and the patient line 20.Alternatively, the valve arrangement 24 may be implemented using twovalves—a first valve used to open a path between the patient line 20 andthe drain line 18 and a second check valve used to open a path betweenthe fluid source 22 and the patient line 20 when fluid is pumped fromthe fluid source 22 into the patient's stomach via connection 14 (shownin FIG. 1). In operation, the first valve is opened to drain thecontents of the stomach. The first valve is then closed and fluid ispumped from the fluid source 22 to the patient line 20. Optionally, thefirst valve may be closed automatically by the fluid when the fluid ispumped from the fluid source 22. The first valve may then be re-openedto drain content of the stomach when fluid is no longer pumped to thepatient line 20.

Other embodiments may include a plurality of valves, such as shown inFIG. 3. FIG. 3 schematically shows an assembly 16 having a check valve,valve A, in communication with the fluid source 22 and also with twovalves, valve B and valve F. Valve B is in communication with a checkvalve, valve C, which is in communication with the connection 14 (shownin FIG. 1) via the patient line 20. Valve F is in communication with acheck valve, valve E, which is in communication with the drain line 18.Another valve, valve D is in communication with the patient line 20 andthe drain line 18. Valve B and valve F may be coupled, such that valve Bis opened when valve F is closed, and valve F is opened when valve B isclosed. In operation, valve B is opened while valve F is closed. Valve Dmay then be opened to drain the contents of the stomach received fromthe patient line 20. Optionally, the system may be configured so that asfluid is pumped through valve B and valve C, the movement of the fluidcloses valve D and permits the fluid to flow into the stomach throughthe patient line 20. When fluid is no longer pumped through valves B andC, valve D may be activated automatically or manually to re-open todrain content of the stomach. When finished removing content from thestomach, valve D is closed and valve B is closed, which in turn opensvalve F. The fluid may then be pumped through valve A, valve F and valveE to the drain line 18 in order to clean the drain line after use.

Variations on the assembly 16 shown in FIG. 3 may be implemented usingone or more pumps in communication with the valve arrangement 24, thefluid source 22 and/or the drain line 18. For example, a pump may becoupled between the fluid source 22 and the patient line 20 with a checkvalve in communication with the fluid source 22 and the pump and anothercheck valve in communication with the pump and the patient line 20 tofacilitate fluid flow to the connection 14 (shown in FIG. 1). A pump maybe coupled between the patient line 20 and the drain line 18 with acheck valve in communication with the patient line 20 and the pump andanother check valve in communication with the pump and the drain line18. A pump may also be provided by the squeezing of a hand, e.g.,squeezing the fluid source. A combination of two or more pumps may beused, to facilitate fluid flow to the patient line 20, to the drain line18, or both. For example, during operation, if the system becomesclogged with content of the stomach such that the draining and/orinfusing is not functioning properly, a pump may be provided to clearthe obstruction in the patient line 20 and/or the drain line 18. Varioustypes of pumps may also be used, such as, but not limited to, adiaphragm pump, a spring loaded piston pump, a syringe pump, aperistaltic pump, a flexible vein pump, a pneumatically actuated pump ora combination thereof. The pump(s) may be removable from the system suchthat a pump is only provided when necessary.

Referring now to FIGS. 2 and 3, a removable syringe may be provided atan auxiliary port 25 to provide suction for removing clogs from thepatient line 20 and/or drain line 18. Although various configurationshave been discussed for the valves and pumps with respect to FIGS. 2 and3, it will be apparent to those skilled in the art that any number,kind, and/or configuration of valves and pumps may be used.

FIGS. 4 and 5A-5C show an embodiment of a system for removing ingestedmaterial from the stomach. In this embodiment, the system includes thefluid source 22, the drain line 18, and the patient line 20 and alsoincludes an actuation handle 26 for opening and closing a path betweenthe patient line 20 and the drain line 18 and for opening and closing apath between the fluid source 22 and the patient line 20. In operation,the actuation handle 26 may toggle the assembly 16 between two modes, adrain mode and an infusion mode. For example, in the drain mode, theactuation handle 26 may be in its original or un-actuated position whichmay cause the path between the patient line 20 and the drain line 18 tobe opened and the path between the fluid source 22 and the patient line20 to be closed, thus permitting content of the stomach to be drained.When the actuation handle 26 is squeezed or actuated, the actuationhandle 26 causes the path between the patient line 20 and the drain line18 to be closed and the path between the fluid source 22 and the patientline 20 to be opened. The actuation handle 26 causes the fluid source 22to be squeezed or pumped, forcing the fluid out of the fluid source 22,thus allowing fluid to flow into the stomach in the infusion mode. Forexample, a user may squeeze the actuation handle 26 and fluid source 22by hand. When the actuation handle 26 is released, the actuation handle26 is returned to its original position, e.g., by a spring force, suchas an extension spring, causing the path between the patient line 20 andthe drain line 18 to be re-opened and the path between the fluid source22 and the patient line 20 to be re-closed. The actuation handle 26 maycause the various paths to be opened or closed using any of a variety ofapproaches that will be apparent to persons skilled in the relevantarts, e.g. by pressing or pinching the various fluid lines or actuatingvalves.

Still referring to FIGS. 4 and 5A-5C, the system may also include apatient line cap 28 and a patient port plug 30 for when the system isnot in use and removed from the patient. For example, the assembly 16may be removed from the patient line 20 and the patient line cap 28 maybe used to terminate the patient line 20. Similarly, the patient portplug 30 may be used to plug the opening where the patient line 20couples to the assembly 16.

The assembly 16 may also include a rinse slide 32 for opening andclosing a path between the fluid source 22 and the drain line 18. Afterthe system is used to infuse fluid into the stomach and drain contentsout of the stomach, the fluid source 22 may be used to rinse out orclean the patient line 20, the drain line 18 or both. Upon completion ofuse, the actuation handle 26 may be squeezed with the fluid source 22 tocause fluid to flow through and clean the patient line 20. Once thepatient line 20 is clear, the patient line 20 may be clamped while stillholding the actuation handle 26 and the patient line 20 may bedisconnected from the assembly 16. The actuation handle 26 may then bereleased. In order to clean the drain line 18, the rinse slide 32 may beactivated, allowing fluid to flow from the fluid source 22 down thedrain line. When the rinse slide is activated, both valves open andsince the drain line is lower than the fluid source, the fluid flows outof the drain line 18. The actuation handle 26 may then be squeezed withthe fluid source 22, causing fluid to be pumped out of the fluid source22 and through the drain line 18, cleaning the drain line 18.

Referring now to FIG. 4, optionally, the system may include anattachment mechanism 34 such as a belt clip, for attaching the assembly16 to the patient during use of the system. Now referring to FIGS. 4 and5A-5C, the attachment mechanism 34 may be coupled to the assembly 16 atan attachment location 36. The fluid source 22 may be coupled to theassembly 16 at an attachment assembly 38.

FIGS. 6A and 6B depict an alternative assembly 16′ that may be used inplace of the assembly 16 depicted in FIGS. 4 and 5A-5C. In thisembodiment an actuation lever 44 alternately either (a) opens a pathbetween the patient line 20 and the drain line 18 or (b) closes the pathbetween the patient line and the drain line. Referring now to FIG. 6B,when the lever 44 is actuated in this embodiment, it causes the pathbetween the patient line 20 and the drain line 18 to be clamped by clamp49 and the path between the fluid source 22 and the patient line 20 tobe opened. When the fluid source 22 is squeezed while the lever 44 is inan actuated position, fluid from the fluid source 22 will flow through acheck valve, into the patient line and into the stomach. When the lever44 is in a non-actuated position, the path between the patient line 20and drain line 18 is open. Upon squeezing the fluid source 22 in anon-actuated position, water flows from the fluid source 22 through thedrain line 18 and causes a rinsing effect, which obviates the need forthe separate rinse slide. In the illustrated embodiment, the actuationlever 44 may cause the paths to be closed/opened by clamp 49 pressing orpinching on the tubing lines. However, persons skilled in the relevantarts will recognize that alternative approaches for opening and closingthe various fluid flow paths may be substituted by making appropriatemodifications.

Since water bottles may have varied thread designs which would notordinarily mate with conventional female fittings, a universal fluidsource receptacle 46 may optionally be implemented to accept any waterbottle neck, and to lock around the bottle neck flange. Upon actuationthe receptacle releases the flange on the fluid source. This feature mayalso be implemented in the other embodiments described herein.

The system is preferably connected to a gastrostomy tube that haspreviously been installed in a patient (e.g., through the patient'sabdominal wall), with a port that extends out of the patient's body.Preferably, the port is relatively flush with the surface of thepatient's abdomen and has a connector that mates with a mating connectorof the system. A variety of ways to implement such a flush mountconnection interface can be readily envisioned.

FIGS. 8-15 depict one preferred implementation of a flush mountconnection interface. One part of the interface is the “skin connector”60 (shown in FIGS. 9-12) which is an implementation of the connection 14discussed above in connection with FIG. 1, and is affixed to the patientand the gastrostomy tube 45 that resides inside the patient's stomach.This embodiment of the skin connector 60 includes a rotational valveassembly that controls opening and closing of the pathway into thestomach, as shown in FIGS. 14A-14B. The other part of the interface isthe “tube connector” 65, also shown in FIGS. 14A-14B, which ispositioned at the upper end of the patient line 20 and is designed tomate with the skin-connector 60 with a fluid-tight interface.

FIGS. 9-11 depict a rotational valve assembly 50 that is assembledinside a skin flange 55 to create a flush mount skin connector 60, andFIG. 12 is an exploded view of the rotational valve assembly 50. Threeof the valve assembly components 81, 82, 83 have a thru-hole biased toone quadrant, arranged so that the valve is opened when the thru-holesare aligned and so that the valve is closed when the thru-holes are notaligned. In the preferred embodiment, the size for the entire valveassembly is about 4 cm in diameter, and the size for the thru-holes isabout 6-8 mm in diameter. However, in other embodiments, the valveassembly can be proportionally different size, either larger or smaller.The valve assembly 50 is preferably constructed of top platform 81 and abottom platform 83, with a layer of elastomer 82 that is attached to thetop platform 81 and sandwiched between the top platform and the bottomplatform 83 with a force that is high enough to prevent leaks, yet lowenough to permit rotation of the elastomer 82 with respect to the bottomplatform 83. The elastomer is attached to the top platform using anyadhesive that would attach the silicon to the plastic, however, in oneembodiment, a primer and a fast curing adhesive is used. The topplatform 81 is preferably made of a lubricious plastic for example,acetyl, and in some embodiments, DELRIN®, TEFLON®, polyethylene, etc,can be used, and the bottom platform 83 is preferably made of ABS oranother hard plastic. However, in alternative embodiments, thosecomponents may be made of other materials that provide similarfunctionality. A top retaining ring 80 is configured to attach to thebottom platform 83 to retain the top platform 81 and the middle layer 82while allowing those two layers to rotate with respect to the bottomplatform 83. Attaching can be in the form of snap fitting, welding,gluing or any other method of attachment. The top retaining ring 80 ispreferably also made of ABS or another hard plastic. In the illustratedembodiment, as best seen in FIGS. 9-11, the valve assembly 50 hasprotrusions 53 at its bottom that allows it to fasten to recesses 56 inthe skin flange 55 to form the skin connector 60. The top face of thevalve assembly preferably has a structure (e.g., the cut-outs 52) formating with a corresponding surface on the tube connector 65. The valveassembly 50 can be disassembled from the skin connector 60 by pushingthe protrusions 53 at its bottom out of the recesses 56 in the skinflange 55. With significant force, manually or with a tool directed atthe bottom of the recesses 56, the barbed protrusions 53 can be freedfrom the recesses 56 in skin flange 55 and the valve assembly 50 can beremoved.

Removal of the valve may be required when a course of treatment isfinished or in connection with valve replacement due to wear, scheduledmaintenance, cleanliness, or length adjustment. Using a removable valvepermits adjustment of the length of the gastrostomy tube (e.g. afterpatient weight loss) to compensate for a shortened stoma tract. Afterthe valve is removed, the tube is cut to a shorter length, and then thevalve is replaced, advantageously avoiding the need to replace thegastrostomy tube.

Due to protrusions 66 on the contacting surface of the tube connector 65being configured to mate and mechanically couple with the cut-outs 52 onthe valve assembly 50 at a rotational distance of approximately 120°from the “open” position of valve assembly 50, fluid will not leak outof valve assembly 50 during tube connector 65 removal (i.e. disc 68 isalways covering the passageway of skin connector 60 prior to removal.)

For a gastrostomy tube designed to aspirate food from a full stomach(i.e. larger diameter to accommodate food particles,) the fluid pressuremay be higher than traditional feeding tubes, and the illustrated valveembodiments can withstand such higher pressures without leaking. Theillustrated valve embodiments are also designed to provide a large,uniform lumen from the tube through the valve. The rotational gasketconfiguration allows sealing of the tube without restricting the lumendimension when the valve is in the “open” position, thereby minimizingthe probability of tube clogging during food aspiration.

FIGS. 13A and 13B depict a tube connector 65 that is connected at theupper end of the patient line 20. The tube connector 65 is designed tomate with the skin connector, and protrusions 66 on the contactingsurface of the tube connector 65 are configured to mate with thecut-outs 52 on the valve assembly 50 (both shown in FIG. 9B). The bodyof the tube connector 65 is preferably constructed of a hard plasticsuch as ABS. The contacting surface of the tube connector 65 ispreferably implemented using a disc 68 made of an elastomeric materialsuch as silicone, with a biased thru-hole 67 that is dimensioned andpositioned to match the thru-hole of the skin connector. In theillustrated embodiment, the tube connector 65 has a ridge 71 around theperimeter of its contacting surface that is configured to fit into amating surface of the skin connector (i.e., the valley 61 around theperimeter of the skin connector 60, shown in FIG. 10C). The outersurface of the illustrated tube connector also has a handle 69 forgrasping by the user and a barbed hollow protrusion 70 that is in fluidcommunication with the thru-hole on the contacting surface for fasteningto the patient line tubing.

Referring now to FIGS. 10C and 12-14, when the tube connector 65 and theskin connector 60 are not mated, the valve assembly 50 on the skinconnector 60 is in a “closed” position, with the thru-hole 51 in the topplatform 81 and the middle layer 82 oriented out of phase with respectto the thru-hole 54 in the bottom platform 83. To connect the tubeconnector 65 and the skin connector 60, the thru-hole 67 of the tubeconnector is aligned with the thru-hole 51 in the top platform 81 of thevalve assembly 50. The tube connector 65 is then turned by grasping thehandle 69 and turning it clockwise. When this happens, the biasedthru-hole 51 in the top platform 81 and the middle layer 82 and thethru-hole 67 in the tube connector 65 will all rotate together intoalignment with the thru-hole 54 in the bottom platform 83 of the valveassembly 50, thereby opening a passage to the gastrostomy tube. Rotatingthe tube connector 65 clockwise also engages mating features 66 on thetube connector with corresponding cut-outs 52 on the valve assembly 50(shown in FIG. 9B) to lock the tube connector 65 to the skin connector.

After the passage is open, removal of ingested material from thepatient's stomach is performed, as described above (optionally inalternation with the infusing of liquids into the patient's stomach).Subsequently, the patient or practitioner rotates the tube connector 65counterclockwise, which causes the thru-hole 67, the biased thru-hole 51in the top platform 81, and the middle layer 82 to all rotate togetheraway from the thru-hole 54 in the bottom platform 83 of the valveassembly 50, to the position shown in FIG. 14A, thereby closing thevalve in the skin connector 60. The tube connector 65 can then be pulledaway from the skin connector 60.

Referring now to FIGS. 10-11, the skin connector 60 is preferablyconstructed with an outer skirt 58 composed of a soft, compliantmaterial (e.g. elastomer, foam, etc.) that tapers the fully assembledlow-profile skin-port towards the skin to provide a more aestheticappearance, to prevent the skin connector 60 from catching on the user'sclothing, and to serve as a bumper against applied stresses. Inalternative embodiments, the skin connector 60 and tube connector 65 canbe configured in various other forms and/or can use different materialsto optimize various characteristics. For example, both the skinconnector 60 and tube connector 65 can be made with an oblong shape. Themating features and turning of the valve can be actuated by alternatemeans that will be apparent to persons skilled in the relevant arts,including but not limited to thumbwheel mechanisms, scissor mechanisms,etc.

One potential side-effect of aspirating food from the stomach islowering of electrolytes, such as potassium. The removal of hydrochloricacid (HCl) from the stomach along with food particles can cause thehuman body to excrete potassium to maintain a charge balance, andexcretion of too much potassium can cause hypokalemia. One method forpreventing hypokalemia is to give the patient potassium supplements anda proton pump inhibitor.

Another method for preventing hypokalemia is to selectively remove HClfrom the extracted material, and return it to the patient's stomach, inorder to prevent electrolyte imbalance and obviate the need foradditional therapeutics. To achieve acid return to the stomach, thedevice may be configured with one or more semi-permeable filters thatselectively screen out waste product and retain HCl for return to thestomach. Examples of suitable filters include mechanical filters,chemical filters, ionic membranes (e.g. anionic exchange membrane,cationic exchange membrane, bipolar membrane), and electrochemicalfiltrations systems (or a combination of the above).

One way to implement food evacuation with the return of acid to thestomach is by using two filters in series. The first filter, orpre-filter, separates food particles from the fluid. Examples ofsuitable filters for performing this function include mechanical filterslike standard glass-fiber or cellulose filters that selectively removesolids above a specified particle size, leaving “waste” fluid. Asuitable porosity for such a filter is 2.5 μm porosity. The secondfilter removes hydrochloric acid from the pre-filtered fluid. Examplesof suitable filters for performing this function include semi-permeablemembranes, or an anionic exchange membrane (e.g. NEOSEPTA™, Tokuyama,Japan).

FIG. 7A depicts a first embodiment for returning acid to the stomach. Asiphon effect or a pump is used to force evacuated stomach contentsthrough the pre-filter 110 and into one compartment 122 of a dualchamber container 120, which is separated from the other compartment 126by an anionic exchange membrane 124. The second chamber 126 containsdeionized water. The difference in ionic concentration between the dualchambers of the cell 120 will drive a diffusion dialysis process tooccur in which the Cl⁻ and H⁺ ions from hydrochloric acid selectivelytransfer across the membrane 124 into the water filled chamber 126. Thewaste fluid can then be released to exit to the toilet, and a pump 130can then be actuated to force the HCl and water solution back into thepatient's stomach. FIG. 7B depicts an alternative embodiment that issimilar to the FIG. 7A embodiment, but adds a separate water infusionsubsystem 140 to allow the subject to continue to flush and siphon thestomach while the diffusion dialysis process is occurring. More complexfiltration system can also be used, including but not limited toelectrodialysis, or an anode and a cathode to separate charged ions inan electrophoresis like fluid suspension. The electrofiltration processcould potentially decrease the time to remove the HCl from the wasteproduct.

Repeated removal of food from a patient's stomach to achieve weight lossrequires close medical supervision to avoid complications (e.g., a dropin electrolyte levels). It may therefore be desirable for the physicianto ensure that the patient returns for follow-up and blood testing toavoid improper use of the device, or at a minimum have data that revealsthe patient compliance with proper use of the system. A shut-offmechanism may be built into the system to ensure that the patientreturns for such follow-up. The shut-off mechanism preferably operatesbased on some measurement of usage such as the passage of time (e.g., todisable the device after one month), the number of cycles of use (e.g.,to disable the device after 90 uses), or the volume of extracted matter(e.g., to disable the device after 50 liters of material have beenremoved).

The measurement of usage may be implemented by mechanical or electricalmeans, as will be appreciated by persons skilled in the relevant arts(e.g., using a mechanical counter such as a multi-decade gearedmechanism that is incremented using a cam-actuated sprocket, or anelectrical counter that is incremented by a suitable sensor). Suitableevents that can be used to increment the count include, but are notlimited to, the connection of a water bottle to the system, theconnection of the tube connector to the skin connector, etc. Theshut-off mechanism may also be implemented by mechanical or electricalmeans. One example of a suitable mechanical shut-off mechanism is apreloaded spring mechanism that, when actuated, blocks fluid from movingthrough one of the system's tubes. An example of a suitable electricaldevice for implementing shut-off is a solenoid actuated valve, and awide variety of alternatives will be apparent to persons skilled in therelevant arts. The shut-off mechanism may be designed to permanentlydisable the device, in which case the patient would have to obtain a newdevice to continue using the system. Alternatively, it may be configuredto be resettable by a doctor (e.g., using an electronic shut-offmechanism that can be reset by entry of a password or a biometric keysuch as a fingerprint detector). After the patient is examined by thedoctor (e.g., using blood tests to confirm healthy electrolyte levels),the doctor could provide a new device or reset the shut-off mechanism.

One application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: (a)siphoning a first portion of the ingested food out of the patient'sstomach via the gastrostomy tube; (b) infusing liquid into the patient'sstomach via the gastrostomy tube; and (c) siphoning at least some of theinfused liquid out of the patient's stomach via the gastrostomy tube,together with a second portion of the ingested food. Optionally, thismethod may further include the steps of: (d) infusing liquid into thepatient's stomach via the gastrostomy tube; and (e) siphoning at leastsome of the infused liquid out of the patient's stomach via thegastrostomy tube, together with a third portion of the ingested food,wherein step (d) is performed after step (c), and wherein step (e) isperformed after step (d).

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; a first fluid path provided between the connector and adrain port, configured to permit siphoning or pumping food from thepatient's stomach out to the drain port; a second fluid path providedbetween the connector and an input port, configured to permit infusionof liquid from the input port into the patient's stomach; and a fluidcircuit configured to alternately (a) open the first fluid path during afirst interval of time to permit siphoning or pumping food out of thepatient's stomach and (b) open the second fluid path during a secondinterval of time to permit infusion of the liquid in the reservoir intothe patient's stomach.

Another application of some of the above-described embodiments is toimplement a method of removing ingested material from a stomach of apatient fitted with an external gastrostomy connection to the stomach.This method includes: coupling a siphon tube to the connection so as tocreate a siphon system having an aggregate length in excess of 25 cm;and draining content of the stomach through the siphon tube.

Another application of some of the above-described embodiments is toimplement a method of removing ingested material from a stomach of apatient fitted with an external gastrostomy connection to the stomach.This method includes the steps of: pumping a fluid through theconnection into the stomach to increase fluid in the stomach withoutingestion of fluid; and draining content of the stomach through theconnection. Optionally, the fluid may include one or more of thefollowing: water, a nutrient, a medication, and returned gastric juices.

Another application of some of the above-described embodiments is toimplement an apparatus for removing ingested material from a stomach ofa patient fitted with an external gastrostomy connection to the stomach.This apparatus includes: a fluid source for infusing fluid into thestomach through the connection; and a drain line for draining content ofthe stomach received from the connection. Optionally, a siphon system isused for passively draining content of the stomach, preferably usingflat tubing. Optionally, a pump may be coupled to the fluid source forpumping fluid through the connection into the stomach.

Another application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: (a)extracting a portion of the matter contained in the patient's stomachvia the gastrostomy tube; (b) removing stomach acid from the matterextracted in the extracting step; and (c) returning the stomach acidremoved in the removing step to the patient's stomach via thegastrostomy tube. Optionally, the removing step includes the steps of:(i) filtering out solid portions from the matter extracted in theextracting step; and (ii) filtering a liquid resulting from step (i)using a semi-permeable membrane or an anionic exchange membrane. In thisapplication, the extracting step may be implemented by siphoning orpumping.

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; a filter configured to separate stomach acid from othermatter; a first path from the connector to the filter, configured toroute matter extracted from the patient's stomach into the filter; apump configured to pump stomach acid that has been separated by thefilter back into the patient's stomach; and a second path configured toroute the other matter to a waste outlet. In this application, thematter extracted from the patient's stomach may be routed into thefilter by pumping or siphoning. Optionally, this apparatus may furtherinclude a reservoir configured to hold liquid and a pump configured topump the liquid from the reservoir into the patient's stomach via theconnector.

Another application of some of the above-described embodiments is toimplement a method of removing ingested food from a patient's stomachvia a gastrostomy tube that passes through the patient's abdominal wallinto the patient's stomach. This method includes the steps of: providingan apparatus for siphoning or pumping ingested food out of the patient'sstomach via the gastrostomy tube; and limiting the number of times thatthe siphoning or pumping operation can be performed by the apparatus.The number of times that the siphoning or pumping operation can beperformed may be limited by a variety of factors such as (a) elapsedtime from a first use, (b) how many times siphoning or pumping of foodhas been performed, (c) how many times the apparatus has been connectedto the gastrostomy tube, or (d) the volume of matter that has beenextracted from the patient's stomach. Optionally, this method mayfurther include the step of infusing liquid into the patient's stomachvia the gastrostomy tube, wherein the infusing step is performed inalternation with the siphoning or pumping.

Another application of some of the above-described embodiments is toimplement an apparatus for removing food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach. This apparatus includes: a connector configuredto connect to a proximal end of the gastrostomy tube with a fluid-tightconnection; and a first fluid path provided between the connector and adrain port, configured to permit, for a limited number of times only,siphoning or pumping food from the patient's stomach out to the drainport. The number of times that the siphoning or pumping can be performedmay be limited by a variety of factors such as (a) elapsed time from afirst use, (b) how many times siphoning or pumping of food has beenperformed, (c) how many times the apparatus has been connected to thegastrostomy tube, or (d) the volume of matter that has been extractedfrom the patient's stomach. Optionally, this apparatus may furtherinclude: a reservoir for holding liquid to be infused into the patient'sstomach; a second fluid path from the reservoir to the connector,configured to permit infusion of the liquid in the reservoir into thepatient's stomach; and a fluid circuit configured to alternately (a)open the first fluid path during a first interval of time to permitsiphoning or pumping food from the patient's stomach and (b) open thesecond fluid path during a second interval of time to permit infusion ofthe liquid in the reservoir into the patient's stomach.

Note that while the system is described herein in the context ofremoving the ingested material from the patient's stomach, it can alsobe used to remove the ingested material from other portions of thepatient's upper digestive tract (e.g., the jejunum).

Although the above discussion discloses various exemplary embodiments ofthe invention, it should be apparent that those skilled in the art canmake variations and modifications that will achieve some of theadvantages of the invention without departing from the true scope of theinvention. Accordingly, other embodiments are within the scope of thefollowing claims.

1. A method of removing ingested food from a patient's stomach via agastrostomy tube that passes through the patient's abdominal wall intothe patient's stomach, the gastrostomy tube having a first connector,the method comprising the steps of: providing an apparatus thatalternately mates with and un-mates from the first connector, whereinthe apparatus is configured to facilitate siphoning or pumping ingestedfood out of the patient's stomach via the gastrostomy tube when theapparatus is mated with the first connector, and wherein the apparatusincludes (a) an electrical or mechanical counter that is configured tocount how many times the apparatus has been connected to the firstconnector and (b) a shut-off mechanism configured to disable theapparatus when a predetermined count of connections is reached; countinghow many times the apparatus has been connected to the first connectorby using said electrical or mechanical counter; and activating theshut-off mechanism to disable the apparatus when the count of how manytimes the apparatus has been connected reaches a predetermined number.2. The method of claim 1, further comprising the step of: infusingliquid into the patient's stomach via the gastrostomy tube, wherein theinfusing step is performed in alternation with the siphoning or pumping.3. The method of claim 1, wherein the shut-off mechanism is configuredto permanently disable the device.
 4. The method of claim 1, wherein theshut-off mechanism is configured to be resettable.
 5. An apparatus forremoving food from a patient's stomach via a gastrostomy tube thatpasses through the patient's abdominal wall into the patient's stomach,the gastrostomy tube terminating in a first connector, the firstconnector including a valve assembly that controls opening and closingof a pathway into the patient's stomach, the apparatus comprising: asecond tube that terminates in a second connector, wherein the secondconnector is configured to mate with the first connector and actuate thevalve assembly, so that (a) when the second connector is mated with thefirst connector, the valve assembly is moved to a position that opensthe pathway into the patient's stomach, and a fluid path is establishedbetween the gastrostomy tube and the second tube with a fluid-tightconnection that facilitates siphoning or pumping food from the patient'sstomach out via the second tube, and (b) when the second connector isun-mated from the first connector, the valve assembly is moved to aposition that closes the pathway into the patient's stomach; a counterconfigured to count how many times the second connector has beenconnected to the first connector, wherein the counter comprises anelectrical counter or a mechanical counter; and a shut-off mechanismthat is configured to disable the apparatus after the counter reaches apredetermined count.
 6. The apparatus of claim 5, further comprising: areservoir for holding liquid to be infused into the patient's stomach; asecond fluid path from the reservoir to the connector, configured topermit infusion of the liquid in the reservoir into the patient'sstomach; and a fluid circuit configured to alternately (a) open thefirst fluid path during a first interval of time to permit siphoning orpumping food from the patient's stomach and (b) open the second fluidpath during a second interval of time to permit infusion of the liquidin the reservoir into the patient's stomach.
 7. The apparatus of claim5, wherein the shut-off mechanism is configured to permanently disablethe device.
 8. The apparatus of claim 5, wherein the shut-off mechanismis configured to be resettable.